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SESSION 11: Biosimilars
Session Chair(s)
Ali AlSamil
Head of Biotech and Biosimilar Products Department, Saudi Food and Drug Authority (SFDA), Saudi Arabia
SESSION 10: Biosimilars
Speaker(s)
Ali AlSamil
Head of Biotech and Biosimilar Products Department, Saudi Food and Drug Authority (SFDA), Saudi Arabia
Introduction & Setting the Scene – Evolution and Global Efforts (IPRP and ICH)
Sarah Yim, MD
Director, Office of Therapeutic Biologics and Biosimilars, OND, CDER, FDA, United States
Global Perspectives - Evolution of the Regulatory Framework for Biosimilars, Experiences and Lessons Learned
Mohammed H. Aldosari, PHD
Director of Biological Products Directorete, Saudi Food and Drug Authority (SFDA), Saudi Arabia
Global Perspectives - Evolution of the Regulatory Framework for Biosimilars, Experiences and Lessons Learned
Anne Cook
Expert Quality Assessor (Biologicals) Healthcare, Quality and Access group, Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
Global Perspectives - Evolution of the Regulatory Framework for Biosimilars, Experiences and Lessons Learned
Andrea Laslop, MD
Former Head of Scientific Office, AGES & Regulatory expert, lecturer, Malta Medicines Authority, University of Innsbruck, Austria
Global Perspectives - Evolution of the Regulatory Framework for Biosimilars, Experiences and Lessons Learned
Virginia Acha, PHD, MSC
Global Lead, Global Regulatory Policy, Merck & Co., Inc., United States
Industry Perspective
Panellist(s) Invited
, Qatar
Panel Discussion with Q&A (With the additional participation of):
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